Identification of risk factors for carbamazepine-induced serious mucocutaneous adverse reactions: A case-control study using data from spontaneous adverse drug reaction reports

Abstract

Objectives:To identify risk factors other than genetic for severe carbamazepine-induced mucocutaneous reactions, that is, SJS, TEN, and exfoliative dermatitis (ED).Materials and Methods:We did a case-control study using data from the Swedish national database of spontaneously reported adverse drug reactions (ADRs). We selected all patients who had been reported from January 1, 1965 to March 31, 2010 as having experienced SJS (n = 78), TEN (n = 6), or ED (n = 8), and assessed as at least possibly related to carbamazepine. We also included diagnoses possibly representative of early signs of these serious conditions, that is, erythema multiforme (EM, n = 34) and scaly rash (n = 13). We compared data on demographics, drug treatment, and clinical features for these patients (cases, n = 139) with those from patients who had experienced any other type of ADR from carbamazepine during the same time period (controls, n = 887).Results:After adjustment for multiple comparisons, alcohol abuse was statistically significantly more common among cases than controls (34.5% vs 8.7%, odds ratio 5.5 [95% confidence interval 3.6-8.4], P = 3.14 × 10-14 ). The same was seen for SJS and EM individually.Conclusion:Alcohol abuse is a possible risk factor for serious carbamazepine-induced mucocutaneous reactions.

Identification of Risk Factors for Bisphosphonate-Associated Atypical Femoral Fractures and Osteonecrosis of the Jaw in a Pharmacovigilance Database

“…The study base and methodology was the same as described in a previously published report of risk factors for carbamazepine-induced serious cutaneous reactions. 13 Briefly, SWEDIS contains reports of ADRs sent by Swedish health care professionals, predominantly physicians, to the Swedish Medical Products Agency (MPA) since 1965, as described. 14,15 A Swedish dictionary is used for coding ADRs, built on a 3-level hierarchical structure developed by the MPA (Swedish adverse reaction terminology, SWE-ART).…”

Identification of risk factors for adverse drug reactions in a pharmacovigilance database

“…However, since a wide range of different ADRs are reported for a drug, and since such reports stem from patients with a similar treatment indication, it should be possible to use patients with other ADRs to the same drug as controls, in order to discover potential new risk factors. Our research group has previously applied this technique to data in the pharmacovigilance database kept by the Swedish Medical Products Agency (SMPA) in data mining studies where we let reports of an ADR of interest serve as cases, and all other reports for the same drug as controls 7,8 …”

“…Our research group has previously applied this technique to data in the pharmacovigilance database kept by the Swedish Medical Products Agency (SMPA) in data mining studies where we let reports of an ADR of interest serve as cases, and all other reports for the same drug as controls. 7,8 In the current study, we further investigate whether this methodology could identify possible risk factors for bleeding during treatment with direct oral anticoagulants (DOACs). If so, we should be able to detect known, and possibly yet unidentified risk factors.…”

Treatments that generate higher number of adverse drug reactions and their symptoms

“…Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide [1][2][3][4] and generate high health costs [5][6][7] . There are many different definitions but the most accepted is granted by the World Health Organization (WHO), and is defined as any noxious, undesirable reaction that occurs with the doses used routinely in humans for the treatment, prophylaxis or diagnosing a disease [8][9][10] .…”